Mandatory Heavy Metal Testing for Ayurvedic Drugs from Jan 1, 2006

Posted AtPharmaBiz

The Central Government has made testing
for heavy metals mandatory before export of herbal medicines
and the rule is to take effect from January 1, 2006.
The containers of these medicines are to clearly display
that "heavy metals are within permissible limits".

According to a recent notification, the permissible
limits for arsenic, lead and cadmium will be as recommended
by WHO on quality control methods for medicinal plants
and materials. In case of mercury, the permissible limit
will be one ppm. The manufacturers of Ayurveda, Siddha
and Unani, who do not have in-house laboratory facilities,
will have to get these tested by any approved drug-testing
laboratory.

However, the labelling is to continue as a self-certification
process exclusively meant for exports. The responsibility
for batch-wise testing would solely be on the drug manufacturers.
The process of self-certification would be extended
in due course for medicines being sold within the country.
An official note from the Department of Ayurveda, Yoga
and Naturopathy, Unani, Siddha and Homeopathy (AYUSH)
states that due to environmental pollution and unsatisfactory
agricultural and collection practices relating to the
medicinal plants that are used in the preparation of
these drugs, the presence of heavy metals above permissible
limits, cannot be ruled out. Hence, it has become necessary
to make testing for heavy metals mandatory in every
batch of these medicines, before export.

It should be noted that the Indian directive comes in
the wake of the recent alerts issued by the health regulatory
agencies of UK and Canada against Indian Ayurvedic products
on the complaints of high-level toxic metal content.
Both the regulatory agencies had issued warning notices
against a list of ayurvedic medicines allegedly having
metallic content beyond permissible limits.

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